See more Collapse

Associate Director Quality Assurance

1 month ago

Dublin, Ireland AbbVie Full time
Job Description

We are now hiring a Quality assurance Associate Director on our AbbVie Dublin site in Clonshaugh for a 23 month contract.

The Quality Assurance Associate Director manages the Quality Systems and Design group within the Quality Assurance Department at AbbVie Ireland Clonshaugh and is responsible for developing, implementing and maintaining site compliance strategies and Quality Systems.  The Associate Director is responsible for staying current with proposed and implemented regulations and understanding industry trends.  This position interfaces and collaborates with corporate and other site management in assuring that AbbVie Ireland Clonshaugh is fully compliant with HPRA, FDA and corporate standards.  The Associate Director is responsible for transitioning developmental products into AbbVie Ireland Clonshaugh Quality Systems and overseeing compliance for the site manufacturing and supply chain operation.   The Associate Director is an expert in current Good Manufacturing Practices and manages many of the site key Quality Systems.  The Associate Director is a key participant in site regulatory agency inspections.  This position supervises a team of QA Technicians and reports to the Director, Quality for the site.

Responsibilities:

  • Provide strategic and tactical direction for Quality Systems design and maintenance.
  • Manage key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control, Labeling Artwork Approval, Technical Agreements and Site Master File.  Measure and report site performance on key indicators of these quality systems through metrics. 
  • Ensure quality system performance is appropriately and well communicated throughout site.  Provide guidance and assessments on other site Quality Systems. 
  • Ensure site applicable aspects of regulatory submissions are appropriately reviewed for consistency between site procedures and methods and regulatory submissions.
  • Ensure site compliance with HPRA, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate.
  • Lead and direct critical out-of-specification (OOS) and deviation investigations.
  • Develop and sustain a culture of constant site readiness for site inspections.  Identify industry trends and implementation strategies to keep the site ahead of the compliance curve and within AbbVie’s budgetary requirements.
  • Develop a support/service mentality in Quality staff, partnering with local site departments.
  • Serve as a key participant in site regulatory agency inspections.
  • Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines. 
  • Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations.  This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counseling, building and executing development plans, and providing career counseling for career progression. 
  • Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives.
  • Provide hands on training, support, and coaching to reports and make timely decisions to ensure that performance Service Level Agreements (SLAs) can be met.
  • Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.

Qualifications

  • Bachelor’s Degree or above in Chemistry, Pharmacy or related Science.
  • At least 5 - 7 years relevant Pharmaceutical Quality experience and 3-5 years supervisory experience.  This experience does not have to be limited to Quality Assurance.
  • Must have excellent understanding of current Good Manufacturing Practices and manufacturing operations
  • Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
  • Experienced and knowledgeable in EU and FDA cGMPs
  • Experienced in interacting with regulatory authority inspectors
  • Experience in managing by metrics
  • Experienced in aligning individuals and teams to business objectives
  • Exposure to Lean manufacturing concepts


Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

We have other current jobs related to this field that you can find below

  • Associate Director Quality Assurance

    4 weeks ago

    Dublin, Dublin City, Ireland AbbVie Full time

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

  • Senior Quality Assurance Associate

    1 week ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC Biotech  Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...

  • Audit and Assurance Director

    4 weeks ago

    Dublin, Dublin City, Ireland RSM Ireland Full time

    About RSM Ireland RSM Ireland is one of the country's fastest growing advisory firms, specialising in the provision of consulting, audit, and tax services to leading domestic and international mid-market clients. We are a key member of the RSM International network and work closely with over 64,000 colleagues in 820 offices, spanning 120 countries. RSM...

  • Associate Director

    4 weeks ago

    Dublin, Dublin City, Ireland Gsecure Full time

    Associate Director - Transportation & InfrastructureReporting to: Transportation & Infrastructure Director UK&ILocation: Dublin or CorkOur client, a prominent independent consulting and engineering services group with over 50 years of experience, is seeking an Associate Director specializing in the railways/highways sector to join their growing team in...

  • Senior Quality Assurance Associate

    1 week ago

    Dublin, Ireland TEAM HORIZON Remote Work Freelance Full time

    Description Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin. Why you should apply: This is an excellent opportunity to join a forward thinking company and work in a state of the art facility. What you will be doing: Testing of primary and secondary...

  • Associate Director

    4 weeks ago

    Dublin, Dublin City, Ireland Clarity Search Partners Ltd Full time

    Associate Director - Audit and Assurance | Top 5 Firm | Dublin 1 The Client —Our client is prominently positioned as one of Ireland's foremost growing professional service firms, strategically poised for ongoing development and expansion in the forthcoming years. Their core commitment revolves around fostering an environment that fosters the personal and...

  • Director of Quality

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Director of Quality, Dublin My client, a global pharma company have a new and exciting opportunity for a Director of Quality to join the Dublin site. As the Quality Director for their Dublin site, you are positioned at the heart of their operations, blending site-specific duties with a role on the global quality leadership team. Your position will have an...

  • Quality Assurance Tester

    4 weeks ago

    Dublin, Dublin City, Ireland Allen Recruitment Consulting Full time

    Our client is an international software R&D company delivering cutting edge solutions and multiple software products in the MedTech / MedDevice sector. They are currently looking for an experienced Quality Assurance Testerto join them on a permanent basis in a hybrid role in Dublin.You'll team up with fellow QA Engineers, guided by the QA Manager, to enhance...

  • Compliance Assurance Associate

    4 weeks ago

    Dublin, Dublin City, Ireland Ramp Full time

    What you will be doingWe're looking for a Compliance Assurance Associate to support in the delivery of our global compliance assurance and testing programme. This role will also be involved in horizon scanning for upcoming regulatory changes relevant to the organization and ensuring Ramp's voice is heard in relevant industry forums and associations. This is...

  • Associate Director

    4 weeks ago

    Dublin, Dublin City, Ireland Norconsulting Full time

    Dublin, D, Ireland Associate Director - Senior HydrologistJob Description: Associate Director/Senior HydrologistDue to significant growth in our client's Water and Flood Risk Management Business in Ireland and internationally, we are currently recruiting for an Associate Director/Senior Hydrologist to join the I Flood Risk Management team. The role will...

  • Associate Director Risk Management

    1 month ago

    Dublin, Ireland Carrier Full time

    About This Role This position will provide you with the unique opportunity to work within a risk management department with enterprise-wide responsibility of a company with a dynamic, global risk profile. As a member of the risk management team, this role will work with multiple Corporate and business functions to support Carrier's global international...

  • Global Head Of Quality Operations

    4 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    The Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS).This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide.Strategies will...

  • Global Head of Quality Operations

    4 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    The Head of Quality Operations is the Quality Business Partner for Alexion Operations, Information Technology (IT) and Product Development & Clinical Supply (PDCS). This role leads the strategy and execution for quality assurance and quality control at Alexion's Manufacturing Facilities and Contract Manufacturing Organizations (CMOs) worldwide. Strategies...

  • Head of Quality Assurance

    5 days ago

    Dublin, Dublin City, Ireland ICD Business School Full time

    Join our TeamJob Vacancy: Head of Quality Assurance – ICD Business School, Dublin Institution DescriptionEstablished in 2001, ICD Business School is a higher education institution in Dublin City, accredited by QQI. Our programmes at NFQ levels 8 & 9 offer up to 9 ACCA exemptions. As an institution specialising in accounting and finance, in May 2024, ICD...

  • Senior Manager, IRT Development Supply Quality

    4 weeks ago

    Dublin, Dublin City, Ireland Quality Analytics Full time

    This is what you will do:The senior manager for IRT Development Supply Quality will provide quality oversight and support to the Product Development - Clinical Supply (PDCS) IRT team in ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems supporting our clinical studies.This role...

  • Associate Director

    4 weeks ago

    Dublin, Dublin City, Ireland Prosperity Full time

    ***For this role the chosen candidates can either work from our client's Dublin offices with regular commute to Saudi Arabia, or relocate to Saudi Arabia*** We are looking for Senior Associate Directors for one of the most impactful and prestigious agencies in the world. They are experiencing a new phase of growth, with a significant recent conversion...

  • Associate Director

    1 month ago

    Dublin, Ireland Prosperity Full time

    ***For this role the chosen candidates can either work from our client's Dublin offices with regular commute to Saudi Arabia, or relocate to Saudi Arabia***  We are looking for Senior Associate Directors for one of the most impactful and prestigious agencies in the world. They are experiencing a new phase of growth, with a significant recent conversion...

  • Audit Associate Director

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Our client has an urgent requirement for an Audit Associate Director to join their growing team.Audit Associate DirectorContract Type: Full-time Permanent.Responsibilities:Project Management: Efficiently managing a diverse and extensive client portfolio, ensuring effective project delivery.Quality Audit Oversight: Ensuring high-quality audit work across...

  • Audit Associate Director

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    Our client has an urgent requirement for an Audit Associate Director to join their growing team.Audit Associate DirectorContract Type: Full-time Permanent.Responsibilities:Project Management: Efficiently managing a diverse and extensive client portfolio, ensuring effective project delivery.Quality Audit Oversight: Ensuring high-quality audit work across...

  • Quality Assurance Advisor

    3 weeks ago

    Dublin, Ireland GMC Utilities Group Full time

    Are you looking to become part of a collaborative team whilst maximising your potential to grow and develop within your career? Apply today. The Role.GMC are currently looking for an experienced Quality Assurance Advisor to join our team. The successful QAQC Advisor will be supporting the delivery of projects across all aspects of the business from a...